Consent forms should contain the basic elements, or additional elements, as
appropriate, included in the Informed Consent
section and follow the format outlined below:
- Each page of the consent form should be on Wofford
College letterhead, except in cases of collaborative projects when the
letterhead from a hospital, university, etc. is acceptable. All letterhead
must be the original, not a copy. The official stamp of the IRB will
indicate the date of approval.
- The consent form should be in language understandable
to the subject or his or her legal representative. It must be written in a
consistent voice: either first, second, or third person (not a
- If the research is externally funded, the funding
agency should be listed under funding source.
- The title of the study and the name, address, and telephone
number of the investigator(s) follow immediately after funding source. The
Principal Investigator's address and phone number, and the number of the
IRB Office must appear on the consent form (this is the office number of
the IRB chair). If the principal investigator is a student, the address and
phone number of his/her advisor(s)/ supervisor(s) must also appear on the
- Section I - Description of the Study. This section
should include a statement that the study involves research, the purpose
of the study, the reason for selecting the subject, the procedures to be
used and identification of any procedures which are experimental, and the
expected duration of the subjects participation, including anticipated
- Section II - Risks and Benefits to the Participant.
Subjects should be informed about direct or indirect potential benefits to
them or others or the absence of benefits. Potential or anticipated risks
should also be specified. For research involving more than minimal risk,
explanations as to whether compensation or medical treatments are
available if injury occurs. The section must include the following:
"If [I/you] have any concerns about the risks or benefits of
participating in this study, [I/you] can contact [name of principal
investigator and advisors/collaborators] or the IRB office at the numbers
- Section III - Costs and Payments to the Participant
should be addressed explicitly, including a statement that payments will
not be given if that is the case.
- Section IV - Confidentiality must be specified as well
as a description of procedures for protecting privacy, including specific
information regarding how data will be stored to ensure security and
confidentiality. The confidentiality statement must include in the
statement a clause that reads "all information obtained in this study
is strictly confidential unless disclosure is required by law."
- Section V - Participant's Right to Withdraw from the
Study must include a statement that the subject understands s/he is free
to refuse to participate in or withdraw from the study at any time without
adverse affects or loss of benefits, and that,
if the participant withdraws, the data will be destroyed.
- Section VI - Voluntary Consent by the Participant- The
following voluntary consent paragraph must be used in all consent forms
and must appear in boldface type: "I have read this consent form (or
it has been read to me) and I fully understand the contents of this
document and voluntarily consent to participate. All of my questions
concerning this research have been answered. If I have any questions in
the future about this study they will be answered by the investigator
listed above or his/her staff. A copy of this form has been given to
- Section VII - Other Considerations. Subject needs to be
informed if significant new information relating to the study becomes
available which may relate to his/her willingness to continue to
participate, this information will be provided to him/her by the
Consent forms must provide space for the subject's signature, the date, and
the signature of a witness, generally the member of the research staff
obtaining the consent.
See Sample Consent Form.
Because children under the age of 18 may require simpler language than that
provided in the sample consent form, a sample of the consent form for children
can be found at Sample Child's Assent Form.
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